Zanzibar Association for People Living with HIV/AIDS
Welezo, Zanzibar, Tanzania
NCT Number: NCT05104554
This purpose of this study is to assess effects of iron and folic acid supplementation and multiple micronutrient supplementation on anemia status and school performance/attendance among in-school adolescents in Zanzibar, Tanzania.
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Notify Me10 year–17 year
All sexes
Interventional
Not applicable
Welezo, Zanzibar, Tanzania
This study aims to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health and education in Zanzibar. Findings from this study will clarify the optimal supplementation strategy (iron and folic acid alone or adding other essential nutrients) and provide a basis for scale up of national micronutrient supplementation programs to benefit the adolescent population as a whole in Zanzibar.
This will be a cluster randomized study with 3 arms. At the beginning of the academic year, 42 schools will be enrolled (14 schools per arm) to receive either 1) supplementation with weekly iron and folic acid (IFA); 2) supplementation with daily multiple micronutrient supplements (MMS) (including iron and folic acid as components); or 3) to serve as controls. Students in intervention schools will receive supplementation and students in control schools will receive the usual care (which does not include supplementation but does include existing curriculum on nutrition and water, sanitation and hygiene [WASH]). The program will be evaluated at the end of year 1, comparing effects of weekly IFA and daily MMS on anemia status and school attendance/performance. The more effective strategy (MMS or IFA) will be scaled up to all the study schools for year 2 of the intervention, and the outcomes will be re-assessed.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IFA: Weekly regimen of one tablet containing iron (60 mg) and folic acid (2800 μg)
MMS: Daily regimen of one multiple micronutrient tablet containing fifteen micronutrients in the United Nations International Multiple Micronutrient Preparation (UNIMMAP) preparation. Composition includes vitamin A (800 ug), vitamin D (5 ug), vitamin E (10 mg), vitamin C (70 mg), vitamin B1 (1.4 mg), vitamin B2 (1.4 mg), niacin (18 mg), vitamin B6 (1.9 mg), vitamin B12 (2.6 ug), folic acid (400 ug), iron (30 mg), zinc (15 mg), copper (2 mg), selenium (65 ug), and iodine (150 ug).
Time frame: Up to one year
Anemia will be defined based on the sex- and age- specific WHO cutoffs:
Time frame: Up to one year
Number of days of missed school per student
Time frame: Up to one year
Number of students who drop out of school
Time frame: Up to one year
Percent of students who pass to the next grade at the end of the year
Harvard School of Public Health (HSPH)
Other
Acronym: SAMIA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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